What side effects are associated with this type of intervention?

Physical Therapy (including exercise and manual techniques) for Achilles Tendinopathy is generally safe but may cause temporary soreness or discomfort. Photobiomodulation Therapy (Low-Level Laser Therapy) has minimal side effects, though some patients may experience mild skin irritation or a temporary increase in pain. Shockwave Therapy (High-Energy Acoustic Wave Therapy) can cause transient pain, swelling, or bruising at the treatment site. Overall, these treatments are considered low-risk with manageable side effects.

What prior FDA approvals exist?

There is no specific mention of FDA approvals for the treatment of Achilles Tendinopathy using Physical Therapy, Photobiomodulation Therapy (Low-Level Laser Therapy), or Shockwave Therapy (High-Energy Acoustic Wave Therapy) in the provided context. These treatments are generally considered non-pharmacologic and are often used based on clinical practice guidelines and evidence from clinical trials rather than specific FDA drug approvals.

What other types of research exist?

Emerging alternatives for Achilles Tendinopathy treatment include Platelet-Rich Plasma (PRP) injections, which utilize the patient's own blood components to promote healing, and Stem Cell Therapy, which aims to regenerate damaged tissues. Both therapies have shown promise in clinical trials for reducing pain and improving function. Additionally, Extracorporeal Pulse Activation Technology (EPAT), a non-invasive treatment that uses acoustic pressure waves, is gaining attention for its potential benefits in tendon healing.

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Combination Therapies for Achilles Tendinopathy

N/A

Waitlist Available

Led By Jeremy D Schroeder

Research Sponsored by Musculoskeletal Injury Rehabilitation Research for Operational Readiness

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing different treatments for people with a painful Achilles tendon condition. It looks at regular physical therapy, physical therapy with a special light treatment, physical therapy with a high-energy sound wave treatment, and physical therapy with both light and sound wave treatments. The goal is to find out which combination works best to reduce pain and improve movement.

Who is the study for?

Active duty US Armed Forces members aged 18-64 with a clinical diagnosis of mid-portion Achilles tendinopathy can join. They must be able to read English, commit to a 3-week treatment and 6-month follow-up. Exclusions include recent treatments like dry needling or shockwave therapy, tattoos in the treatment area, pacemaker use, certain heart diseases or medications, current sciatica symptoms, tendon injuries/surgery, other pain studies participation, pregnancy plans during the study period.

What is being tested?

The trial is testing how well different combinations of physical therapy (PT) work for Achilles tendinopathy. It compares standard PT alone versus PT with low-level laser therapy (photobiomodulation), high-energy acoustic wave therapy (shockwave), and both therapies combined. The aim is to find out which method best improves function and reduces pain.

What are the potential side effects?

Potential side effects may include discomfort at the site of treatment from shockwave or photobiomodulation therapies such as redness or swelling. There's also a risk of bruising from physical manipulation during PT sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ankle range of motion

Cross Sectional area

Cross-sectional area

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: PT + Shockwave Therapy (SWT)Active Control2 Interventions

The physical therapy + shockwave therapy arm will receive SWT once a week for three weeks in addition to the PT treatment described above. Twice a week, for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check- in Data Collection CRF). The first check-in of the week will occur in-person after the SWT, if, however, this is not feasible, it may be conducted virtually; the second check-in of the week may occur virtually or in-person. In total, participants will receive one SWT treatment each week (in person) and complete two check-ins each week (remote or in person), for three weeks. The SWT will take approximately 5-20 minutes.

Group II: PT + SWT and PBMTActive Control3 Interventions

The PT + SWT + PBMT arm will receive both SWT and PBMT treatments in addition to PT treatment described above. Participants will receive PBMT twice a week and SWT once a week, for three weeks. The SWT visit may be combined with a PBMT visit in the same week. Up to two times each week after a treatment visit (for three weeks), a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the team member will also ensure the participant is keeping their activity/medication/pain log; the team member will also deliver the DVPRS with supplemental questions. When/if needed, these check-ins may occur virtually. (See Appendix F for check-in data collection CRF). In Part 1, the PT+ SWT + PBMT treatment arm requires 8 visits: 3 for PBMT alone with check- ins (in person), 3 for PBMT \& SWT with check-ins (in person), 6-week follow-up (virtual or in-person), and 3-month follow-up (in person).

Group III: Physical Therapy (PT) OnlyActive Control1 Intervention

Participants in the PT only arm will follow the PT program outlined above. Twice a week for three weeks, a team member will check-in with the participants to ensure physical therapy exercise adherence, and response to treatment. During the second check-in of the week, the study team member will also ensure the participant is keeping their activity/medication/pain log; the study team member will also deliver the DVPRS with supplemental questions. (See Appendix F for Check-in Data Collection CRF). These check-ins may occur virtually or in person. In Part 1, the physical therapy only arm requires 8 visits. The participants will complete 2 check-in visits each week (remote or in person), for three weeks. Follow-up data will be collected at 6 weeks (virtual or in-person) and at 3 months (in-person).

Group IV: PT + Photobiomodulation Therapy (PBMT)Active Control2 Interventions

The physical therapy + photobiomodulation therapy arm will receive PBMT twice a week, for three weeks, in addition to the PT treatment described above. A member of the study team will measure the treatment area according to a standard protocol (Appendix N PBM Dose Calculations), to calculate and determine the treatment time, approximately 5-20 minutes. PBMT will be delivered at 25W.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Physical Therapy (PT) for Achilles Tendinopathy typically involves exercise and manual techniques aimed at improving tendon strength, flexibility, and function. This helps in reducing pain and preventing further injury. Photobiomodulation Therapy (PBMT), or Low-Level Laser Therapy, uses specific wavelengths of light to reduce inflammation and promote tissue healing at the cellular level. Shockwave Therapy (SWT) employs high-energy acoustic waves to stimulate blood flow and cellular repair processes, which can accelerate tendon healing and reduce pain. These treatments are important for Achilles Tendinopathy patients as they target the underlying issues of tendon damage and inflammation, promoting recovery and improving overall tendon health.

Education and exercise supplemented by a pain-guided hopping intervention for male recreational runners with midportion Achilles tendinopathy: A single cohort feasibility study.